Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer

Phase 1

• Conditions: Small Cell Lung Cancer

• Registration Number: NCT01426841
• Lead Sponsor: AHS Cancer Control Alberta

Brief Summary

This study is intended to assess the feasibility of adjusting a radiation plan during its course to accommodate for a shrinking tumor target. The investigators hypothesize that an adaptive radiotherapy (RT) planning strategy for small cell lung cancer (SCLC) patients with chest-confined disease will allow for safe delivery of higher doses of chest RT than a non-adaptive RT planning approach without subjecting normal critical structures to unacceptable doses of radiotherapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-15
• Study Start: 2011-08
• Study First Submitted QC: 2011-08-31
• Study First Posted: 2011-09-01
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-01
• Last Update Posted: 2014-10-02
• Primary Completion: 2015-04
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• patients with histologically or cytologically proven newly diagnosed small cell lung cancer
• chest-confined disease (including bulky intrathoracic disease)
• adequate pulmonary function tests (FEV-1>1.0 L, DLCO>50%)
• patients of childbearing potential must practice adequate contraception
• Age > or = 18 years
• Karnofsky performance status > or = 70
• eligible for concurrent chemoradiotherapy

Exclusion Criteria

• patients who have undergone complete or subtotal tumour resection
• evidence of non-small cell histology
• prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
• prior RT to the thorax or neck
• compromised lung function with inadequate pulmonary function tests (FEV-1<1.0,DLCO<50%)
• pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach	12-24 months	Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach will be measured in centigray

Secondary Outcome Measures

Name	Time	Method
Survival	12-24 months
Local control and patterns of failure	12-24 months	Local control and patterns of failure

Trial Locations

Locations (1)

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada